MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number 381823

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd insyte autoguard shielded iv catheter there was a discrepancy between the lot number on the outer shipping container and the shelf packs.The following information was provided by the initial reporter: this is a report about discrepancy of lot numbers between the shipping carton and the shelf cartons.During incoming inspection performed by bd japan, it was found that the lot# on the shipping carton was 1271324, whereas the lot# on two shelf cartons was 1267157.For the other shelf cartons, the lot# matched that on the shipping carton.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received three photographs which displayed the dispenser boxes are for two different lots.The reported issue was confirmed.To identify if mixed product is likely cause of the defect the device history record was reviewed specifically for line clearance.This tells us what product was manufactured prior to batch 1271324 and if operators performed line clearance.Line clearance did not reveal any incomplete sections and that the second batch received from the customer (batch 1267157) was manufactured right before batch 1271324.This indicates that the defect is most likely the result of improper line clearance.Without the samples for further inspection, it cannot be identified if the units within the package are from lot 1271324 which would indicate the defect as only dispenser box labeling or if the units are from the incorrect lot.As we cannot verify if the units are mixed product the complaint was assessed for mixed/incorrect label.Therefore this was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating an operator error during the packaging process.

Event Description

It was reported while using bd insyte autoguard shielded iv catheter there was a discrepancy between the lot number on the outer shipping container and the shelf packs.The following information was provided by the initial reporter: this is a report about discrepancy of lot numbers between the shipping carton and the shelf cartons.During incoming inspection performed by bd japan, it was found that the lot# on the shipping carton was 1271324, whereas the lot# on two shelf cartons was 1267157.For the other shelf cartons, the lot# matched that on the shipping carton.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14138249
• MDR Text Key: 289523803
• Report Number: 1710034-2022-00195
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381823
• Device Catalogue Number: 381033
• Device Lot Number: 1271324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1